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Local Anesthetic
Tumescent Lidocaine with liposuction for Anesthesia (TLA Trial)
Phase 1 & 2
Waitlist Available
Led By Jeffrey A Klein, MD
Research Sponsored by Klein, Jeffrey A., M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights
TLA Trial Summary
This pharmacokinetic clinical trial is a dose ranging study of lidocaine in tumescent local anesthesia. The goal is to understand the absorption pharmacokinetic of tumescent lidocaine and to determine an objective (statistical) estimate of the maximum safe mg/kg dosage of lidocaine in tumescent local anesthesia without liposuction.
TLA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Peak or maximum serum lidocaine concentration (Cmax) following a given mg/kg dosage of lidocaine delivered by subcutaneous infiltration of tumescent local anesthesia
Secondary outcome measures
Cmax following 45mg/kg tumescent lidocaine has a Normal distribution. We define the probability that Cmax exceeds 6 microgram/ml, the toxic threshold for lidocaine as a function of lidocaine dosage.
TLA Trial Design
2Treatment groups
Experimental Treatment
Group I: Tumescent Lidocaine with liposuctionExperimental Treatment2 Interventions
Determine maximum safe mg/kg dosage of tumescent lidocaine with liposuction
Group II: Tumescent Lidocaine No LiposuctionExperimental Treatment2 Interventions
Determine maximum safe mg/kg dosage of tumescent lidocaine without liposuction
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liposuction
2020
Completed Phase 2
~930
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Klein, Jeffrey A., M.D.Lead Sponsor
4 Previous Clinical Trials
633 Total Patients Enrolled
Jeffrey A Klein, MDPrincipal InvestigatorUniversity of Californiia, Riverside
1 Previous Clinical Trials
100 Total Patients Enrolled
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